کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2123369 1547193 2011 5 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Recommendations for capture, validation and summarisation of data from studies using RECIST
موضوعات مرتبط
علوم زیستی و بیوفناوری بیوشیمی، ژنتیک و زیست شناسی مولکولی تحقیقات سرطان
پیش نمایش صفحه اول مقاله
Recommendations for capture, validation and summarisation of data from studies using RECIST
چکیده انگلیسی

Response Evaluation Criteria in Solid Tumors (RECIST) is commonly used in oncology clinical trials and provides a standard approach for the assessment of treatment. However, data capture, validation and summarisation are complex. This article focuses on managing solid tumour lesion and response assessment data from capture through summarisation. Conventions for capturing lesion data, as well as considerations for data validation and summarisation, are provided. Recommendations are based on a review of data capture forms (including data items and instructions), data validation practices and algorithms for data summarisation across solid tumour studies at a single company. The intent of the authors is to share our experiences at GSK in the spirit of harmonisation by transparently describing our decisions and methods.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: European Journal of Cancer - Volume 47, Issue 5, March 2011, Pages 697–701
نویسندگان
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